Levetiracetam Three Times Daily in Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Levetiracetam.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating Efficacy and Tolerability of Three Times Daily Levetiracetam in Epilepsy Patients
Overview
The purpose of this clinical trial is to evaluate the efficacy and tolerability of Levetiracetam administered three times daily in patients with epilepsy. The primary objective is to investigate whether orally administered Levetiracetam three times daily dosing is superior in seizure-free days compared to standard twice-daily dosing in patients with epilepsy. Key questions include: * Does LEV improve seizure control, as measured by seizure-free days? * What adverse events or safety concerns are observed with LEV treatment? Participants will receive Levetiracetam administered three times daily during the treatment phase. The study will use a self-matched, pre-post design in which each participant serves as their own control. Baseline seizure activity and safety data will be collected prior to LEV initiation and compared with data obtained during the treatment period. Participants will attend scheduled clinic visits for efficacy and safety evaluations and will maintain a daily diary to record seizure frequency and any treatment-related events.
Interventions
- Drug Levetiracetam
Levetiracetam oral (500mg - 1000 mg) tablet three times a day for 12 months
Primary outcome measures
- change in mean number of Seizure-free days [Time frame: within 6 months pre and post interventions]
Secondary outcome measures (1)
- % Adverse events [Time frame: 12 month post interventions]
Eligibility criteria
Inclusion criteria
- Aged 18 years or older.
- diagnosed with uncontrolled Epilepsy of any type (defined as one or more unprovoked seizures in the last 6 months)
- On Levetiracetam monotherapy
- Participants must have a documented history of Levetiracetam use for at least 12 months prior to enrollment.
- on Levetiracetam high dose (1.5 - 3 g daily)
Exclusion criteria
- Younger than Aged 18 years
- Received Levetiracetam intravenous within the last 24hr.
- Co-administered with other antiepileptic drugs
- Received other antiepileptic drugs in the last two weeks.
- Pregnant women.
- Renal impairment (Crcl < 30) or Acute kidney injury
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- King Saud University — Riyadh
Identifiers
NCT: NCT07490769 · SCTR25011502